Gloveon Victor Outer Glove (Amabilia Medical Ab)
by Hartalega NGC Sdn. Bhd. 4 variants
Ref SPI2880Model Polyisoprene Powder Free Surgical Outergloves
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number955100777HNGCTFMD010X7 09551025944370 | Date23 Dec 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Polyisoprene Surgical Gloves
- Model / Reference
- Polyisoprene Powder Free Surgical Outergloves, SPI2880
- Primary DI / UDI-DI
- 09551025944370
- Basic UDI-DI
- 955100777HNGCTFMD010X7
- EMDN Code
- T01010203 Polyisopren surgical gloves
- Device Class
- Class IIa
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- MY-MF-000010459
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Hartalega Ngc Sdn. Bhd.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No